Validation of HyperDetector for SARS-CoV-2

Validation of the HyperDetector Digital Solution Screening Assay for Rapid Screening for Potential SARS-CoV-2 (COVID-19) Infection

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05124496

Enrollment

10000

Registered

2021-11-18

Start date

2020-12-11

Completion date

2021-12-30

Last updated

2021-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-COV2 Infection

Brief summary

To evaluate the HyperDetector as a method to rapidly screen SARS-CoV-2 To determine the sensitivity and specificity of the screening assay performed on oral swab and saliva specimens, compared to a validated RT-PCR COVID-19 method using nasal or nasopharyngeal swabs and to separately collected nasal swabs, oral swabs, oral rinse and saliva samples. To determine the best workflow for using such an assay to reflex suspicious/positive samples to a validated RT-PCR COVID-19 assay.

Interventions

DEVICEScreening Device

Screening device comparing Rt-PCR positive and negative results to HyperDetector results

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Subjects at COVID-19 testing site for Rt-PCR test.

Exclusion criteria

* Minors under the age of 5

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity	By 12/30/2022	To determine the sensitivity of the screening assay
Specificity	By 12/30/2022	To determine the specificity of the screening assay

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026